This is an exciting opportunity for anyone looking to expand their expertise within the life sciences industry.
Tasks & Responsibilities:
- Performing quality assurance tasks (eg. validation of global computerized systems according to GMP inventory)
- Distributing and coordinating quality assurance tasks among the entire organization, and within all departments
- Advising local quality departments
- Provide templates, support in creating of CSV documentation and review and approve of SOP’s, according to the GMP inventory, to assure compliance of systems.
- Support quality assurance tasks, increasing reviewing and approving the validation lifecycle documents/ review and approving of change requests and owning discrepancies.
Background & Experience
- 8+ years of relevant experience in the life sciences sector
- Sound knowledge of cGMP’s or equivalent regulations
- Demonstrated expertise with computer system validation and risk management, change control and discrepancy/CAPA management
- Knowledge of manufacturing and compliance
- Can work in validated or controlled environments
- Proven experience maintaining full compliance to regulations and standards, whilst proposing pragmatic quality approaches
- Proven experience working with SAP / ERP / Serialization Systems
- Previous experience working with HP ALM
- Pays close attention to detail
- Strives for excellence
- A team-player, good communicator, and work with a positive attitude
- Can Multi-task, ability to focus on various tasks at the same time
- Fluent written and verbal communication in the English language
Are you an experienced Quality Assurance Manager looking to work in a hands-on and fast-paced environment? Then please apply online, we look forward to receiving your application!